A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF THOTTAR CHINUNGI CHOORANAM IN THE MANAGEMENT OF MADHUMEGA NOI (DIABETES MELLITUS
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- If during treatment or after treatment
研究概览
简要总结
This study is a Prospective Open Labelled, Single arm, Non-Randomized, Single centric, Phase II Clinical trial to determine the Effectiveness of THOTTAR CHINUNGI CHOORANAM in the management of MADHUMEGA NOI(DIABETES MELLITUS). The trial drug will be administered at the dose of 1-2 gram twice a day 90 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002 , Tamil nadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug THOTTAR CHINUNGI CHOORANAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events(AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients Will be given in OPD facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with symptoms of polyuria, polydipsia, polyphagia,asthenia, nocturia, obesity(metabolic syndrome),numbness,tingling sensation,mood changes and irritability difficulty in concentration.
- •2.Even if patients is having any one among the three (WHO criteria 2019) a.
- •FBS>126mg/dl and <250 mg/dl or b.
- •PBS>200 mg/dl and <350 mg/dl or c.
- •HbA1c>6.5 and <10.
排除标准
- •1.Age below 34 years and above 60 years 2.Type I diabetes mellitus 3.Gestational diabetes 4.Diabetes insipidus 5.Pregnancy 6.Lactating mother 7.Chronic kidney disease 7.Ischemic heart disease.
结局指标
主要结局
If during treatment or after treatment
时间窗: 90 days
FBS became below 126 mg dl & PPBS below 200 mg dl and HbA1c below 6.5
时间窗: 90 days
次要结局
- Reduction of the sign and symptoms of polyuria, polydipsia, polyphagia, asthenia, nocturia, numbness, tingling sensation, nausea, mood changes and irritability, difficulty in concentration(90days)